Organisation and governance

Governance and Legal Affairs

The Policy, Regulatory and International Affairs (BRI) unit is charged with the administrative organisation, decision-making processes, strategic developments, legal procedures and representation of the MEB on the national and international level.

The competition between pharmaceutical companies was clearly visible in the legal proceedings in 2017. For instance, a pharmaceutical company attempted to obtain insight into the dossier of a competing company via the MEB while the competing company tried to prevent that. This led to various legal proceedings in a number of specific medicine dossiers.

Long-lasting proceedings regarding the medicine Cortiment came to an end in 2017. The MEB had refused to grant a marketing authorisation for this application in 2012. However, the marketing authority was ultimately granted to the company Cosmo in the appeal procedure. The company only provided the additional information that was relevant for an assessment of the effectiveness and risks of the medicine in the appeal procedure. The explanation that experts provided about the clinical practice during the hearing was decisive for the MEB in order for the consideration of the benefits and risks to come out in favour of Cortiment. The Council of State confirmed the MEB's decision.

The patented indication of generic pregabaline products is a procedure that already demanded a lot of MEB's attention in 2017. This case is now before the Court of Justice of the European Union. This court will now have to interpret articles 11 and 21 of the Directive 2001/83/EC.

In 2017, 12 hearings were organised in connection with application procedures (for example, for a proposed refusal of a marketing authorisation application) and appeal procedures.

Freedom of Information Act (Wob) requests

The MEB received 56 requests based on the Wob in 2017. Most of the requests concerned information about current marketing authorisation applications at the MEB. The MEB also received more extensive requests. In about ten requests, information was requested from the registration file of a medicine, such as clinical and non-clinical studies, assessment reports or authorisation decisions of changes in the SmPC. In most cases, Wob requests are made by a competing pharmaceutical company.

The court issued a final judgement in the beginning of 2017 in the case of the disclosure of information by the MEB about the medicine articaine, following a Wob request. This case has led to more transparency at the MEB. From now on, the registration dossier is also considered public information. It is assessed per document category and per document whether there are grounds for exceptions preventing disclosure.

Integrity

Independence demands integrity. To ensure this, the MEB has a Code of Conduct and an integrity policy. Employees, external experts and MEB members fill in a ‘Conflict of Interest Declaration’. This takes place when entering into the company's employment or when entering into a contract, and then annually. In the meantime, new interests must be reported. On the basis of the Code of Conduct and the integrity policy, a total of 116 fundamental assessments were conducted in 2017. The result of an assessment can be that limitations are laid down for an employee or MEB member which mean that he or she cannot be involved in certain activities. Limitations applied for 39 employees and 9 MEB members in 2017.

Organisation and quality management

Advisory Board

The Advisory Board advises the MEB independently and critically about the major policy themes and other aspects of the MEB’s tasks.

The Advisory Board met with representatives of the MEB three times in 2017. The position of the MEB and the information provision of the MEB to patients was discussed. The reappointment of the members was also discussed.

The terms of appointment of the members ended on 4 July 2017. Except for Prof. J.E.W. Broerse, the other members all indicated that they were available for reappointment. The MEB has reappointed these members for a period of four years. The MEB also determined that the Advisory Board will gradually be renewed during this period. Prof. J.J.D.J.M. Rademakers was appointed on 1 January 2018 and replaced Prof. J.E.W. Broerse.

The Advisory Board consists of 6 members. The members originate from different social sectors and have specific expertise in the MEB’s areas of expertise. The position, tasks and working procedure of the Advisory Board are documented in the ‘MEB Advisory Board administrative regulations 2013’. These regulations can be found on the MEB website.

The approved minutes of the meetings of the Advisory Board have been published on the MEB website.

Members of the Advisory Board

Prof. D.D. Breimer (chair)

Prof. J.M. van Ree

Dr G.W.M. van Odijk

Prof. H.A. Büller

Prof. J.E.W. Broerse (up to 1 July 2017)

Dr J.A.M. Hulshof

Human Resource Management and Organisation

The HRM&O unit initiated and implemented many extra activities in 2017. To this end, the unit was strengthened both qualitatively and quantitatively.

The right person in the right place

An important project was the implementation of one of MEB’s main strategies: the right person in the right place. In this context, managers were trained to steer employees on results and development by conducting a good dialogue. An impression was formed of the potential of the employees on an organisation level and on an individual level and an overview was made of the career development opportunities of employees (including desired mobility). Employee mobility is facilitated by supporting individual mobility plans. HRM actively participated in the job vacancy and mobility network. Career and mobility workshops were organised in November 2017.

The activities in connection with ‘the right person in the right place’ led to a higher internal and external mobility.

Leadership development

HRM has set up a long-term leadership programme together with representatives of the managers. Managers receive training individually and in groups to enter into dialogues on various topics such as vision on leadership, connected leadership and change management. This programme will continue in 2018.

Other

The restructuring of the ICT/HRM and Management Support units was started in 2017. HRM made an important contribution to this.

HRM carried out the project Government Job Description Matrix so that all employees have now been placed in the correct job and scale classification. The biannual Employee Satisfaction Survey was conducted in 2017. Employee satisfaction on an organisation level has risen across the board compared to 2015.

Quality management and complaints

Quality management

The MEB has been ISO certified since 2017 according to the new ISO standard 9001:2015. The ISO auditors evaluated MEB’s quality management systems in relation to the new standard, and expressed their confidence in the proper functioning of the MEB’s systems. The new standard means an increased focus on the environment in which the organisation operates, risks and opportunities, stakeholder management and managing improvements.

Complaints

14 complaints were received in 2017. 12 of these complaints were well-founded. A well-founded complaints means that the MEB has failed to give a reaction about the status of submission of a case within the response period of three weeks. The number of complaints decreased compared to the previous year. The MEB received 22 complaints in 2016; 19 of these complaints were well founded.